Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components. Updated April 2014.

摘要

We, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research, are recognizing as acceptable for use by you, manufacturers of blood and blood components intended for transfusion subject to United States statutes and regulations, the document entitled Circular of Information for the Use of Human Blood and Blood Components, (Circular) dated November 2013 (November 2013 Circular). The November 2013 Circular provides specific labeling instructions for the administration and use of blood and blood components intended for transfusion. This guidance supersedes the guidance of the same title issued August 2013.